Effect of Zinc and Vitamin A Supplementation on Diarrhea, Physical Growth and Immune Response in Malnourished Children

Summary

Zinc deficiency is common in developing country children, as food intakes are often low, foods from animal sources are infrequently used, the bioavailability of zinc from staple cereal-based diets is limited and zinc losses occur during recurring diarrheal illnesses. Zinc deficiency is associated with impairment in immunological and other defenses against infection and increased rates of serious infections. Due to limitations in currently used biochemical markers, supplementation trials in populations likely to be deficient provide a reliable means of assessing health consequences of zinc deficiency.

A significantly lower incidence and prevalence of diarrhea has been observed in zinc supplemented developing country children in several placebo-controlled trials. The effect of routine zinc supplementation on lower respiratory tract infection is still unclear. We, therefore, evaluated the impact of daily zinc supplementation in a representative sample of children aged 6 to 30 months enrolled from a New Delhi slum area, with a sample size sufficient to determine the impact on the incidence of severe diarrhea and acute lower respiratory infection.

Conditions

• Diarrhea
• Pneumonia
• Acute Respiratory Tract Infection

Interventions

DRUG

Zinc and vitamin A single dose at enrollment

10 mg/day of elemental zinc as zinc gluconate to infants and 20 mg/day to older children

DRUG

Placebo and vitamin A single dose at enrollment

Placebo was plain glucose. Vitamin A 100,000 IU to infants and 200,000 IU to older children

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• World Health Organization

  collaborator OTHER

• Norwegian Council of Universities' Committee for Development Research and Education

  collaborator OTHER

• Society for Applied Studies

  lead OTHER

Principal Investigators

• Maharaj K Bhan, MD · All India Institute of Medical Sciences

• Nita Bhandari, PhD · Society for Applied Studies, New Delhi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

6 Months

Max Age

30 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

1998-02-28

Primary Completion

2000-02-29

Completion

2000-09-30

Countries

• India

Study Locations